| CTRI Number |
CTRI/2025/11/096857 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Single Dose Two Period Two Way Crossover Oral Bioequivalence Study Comparing Vonoprazan as fumarate Tablets 20 mg In Healthy Adult Human Subjects Under Fasting Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Lay Crossover Oral Bioequivalence Study Comparing Vonoprazan as fumarate Tablets 20 mg of BDR Pharmaceuticals International Pvt Ltd India With Voquezna Vonoprazan fumarate Tablets 20 mg of Phathom Pharmaceuticals Inc USA In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0061-25-VONO Version No: 01 Date: 20 Jun 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| BDR pharmaceuticals International Pvt Ltd Engineering Centre 6th floor
9 Matthew Road Opera House Mumbai 400004 India
|
|
|
Primary Sponsor
|
| Name |
BDR pharmaceuticals International Pvt Ltd |
| Address |
Engineering Centre 6th floor
9 Matthew Road Opera House Mumbai 400004 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Lifescience and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committe ECR/84/lndt/TN/2013/RR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vonoprazan as fumarate Tablets 20 mg Manufactured by BDR Pharmaceuticals International Pvt Ltd India |
A Single oral dose of Vonoprazan as fumarate Tablets 20 mg will be administered in each period Total Duration is 11 Days |
| Comparator Agent |
Voquezna Vonoprazan fumarate 20 mg Tablets Distributed by Phathom Pharmaceuticals Inc Buffalo Grove IL 60089 USA |
A Single oral dose of Vonoprazan as fumarate Tablets 20 mg will be administered in each period Total Duration is 11 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by 12-lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments
Willing to consume ovo lacto vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period
If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject’s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Vonoprazan or its inactive ingredients Allergic reaction symptoms may include trouble breathing rash itching and swelling of your face lips tongue or throat
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and caffeine-containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
Subjects who have taken an unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study
Subject who had participated in any other study within the 90 days of check-in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period
Positive results for alcohol test prior to check-in of each period
Any blood donation / excess blood loss within 90 days of check-in
Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in
Use of hormone replacement therapy for a Period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females likely to become pregnant during conduction of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Vonoprazan as fumarate Tablets 20 mg Manufactured by BDR Pharmaceuticals International PvtLtd India With Voquezna Vonoprazan fumarate 20 mg Tablets Distributed by Phathom Pharmaceuticals Inc Buffalo Grove Il 60089 USA In Healthy Adult Human Subjects Under Fasting Conditions |
25 Time points
00.00 Hrs 00.08 Hrs 00.16 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.33 Hrs 01.67 Hrs 02.00 Hrs 02.33 Hrs 02.67 Hrs 03.00 Hrs 03.33 Hrs 03.67 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 24.00 Hrs and 48.00 Hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fasting conditions |
25 Time points
00.00 Hrs 00.08 Hrs 00.16 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 01.33 Hrs 01.67 Hrs 02.00 Hrs 02.33 Hrs 02.67 Hrs 03.00 Hrs 03.33 Hrs 03.67 Hrs 04.00 Hrs 04.50 Hrs 05.00 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 10.00 Hrs 12.00 Hrs 24.00 Hrs and 48.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| Date of Study Completion (India) |
02/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At least 32 number of healthy adult human subjects will be recruited to evaluate the bioequivalence of Test product with the Reference product As per the discretion of the Investigator a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 32 subjects in period I alone Note If needed the study will be conducted as batch wise In
each period subjects will be housed in the clinical facility for at least
11.00 hours pre-dose to 48.00 hours post-dose, A washout period of at least 07 days
will be maintained between each dosing period In each period after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of either the test product T or reference product R will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre dose 00.00 hour within 75 minutes of before dosing and at 01.00 03.00 06.00 12.00 and 24.00 hours ± 60 minutes post dose Physical examination and vitals will be recorded before check in check out 48.00 hours for each period and at any time if necessary |